UK

United Kingdom · Legal · Senior (5-8 years)

Senior Medical Device Legal Specialist

Here is the whole job, in plain words. What it is, what you decide, how you're judged, how people get here and where they go next. Then the part no course gives you: twelve AI tutors who learn your work.

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  • Experience bandSenior (5-8 years)
  • Direct reportsNo direct reports
  • Reports toLead Counsel, Medical Device Regulatory
  • UK framework levelUsually a manager, or the deepest specialist in a team

Also advertised as Senior Regulatory Counsel (Medical Devices) · Legal Advisor, MedTech Compliance · Senior Legal & Regulatory Affairs Specialist

Built on 43,079 real UK job descriptions we analysed · grounded in qualifications employers recognise

Two short quizzes about you

1From this job to a course

The qualifications matched to this job

GQA Level 5 Diploma in the Practice of Process Safety Management GQA Qualifications Limited · Level 5 · covers 3 of 9 standards
FDQ Level 3 Certificate for Proficiency in Food Manufacturing Excellence FDQ Limited · Level 3 · covers 3 of 9 standards
ProQual Level 3 Award in Providing Initial Legal Advice ProQual Awarding Body · Level 3 · covers 1 of 9 standards
FDQ Level 3 Diploma for Proficiency in Food Manufacturing Excellence FDQ Limited · Level 3 · covers 1 of 9 standards
GQA PAA\VQ-SET Level 3 Diploma for a Bulk Storage Operator (Technician) GQA Qualifications Limited · Level 3 · covers 1 of 9 standards

Matched from the standards this job is measured against: a suggestion, not an official ruling.

The units you would start with

Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety GQA Level 5 Diploma in the Practice of Process Safety Management
Manage compliance to support achieving excellence in food operations FDQ Level 3 Certificate for Proficiency in Food Manufacturing Excellence
Principles of Safe Manufacture of Quality Medicines in the Pharmaceutical Environment Open Awards Level 3 Technical Occupational Entry in the Principles and Practice for Pharmacy Technicians (Diploma)
Providing initial health and community care legal information and advice ProQual Level 3 Award in Providing Initial Legal Advice
Comply with External and Internal Obligations within a Bulk Storage Operations Environment GQA PAA\VQ-SET Level 3 Diploma for a Bulk Storage Operator (Technician)

The future skills this job leans on

AI Fluency working with AI as a thinking partner
Data Fluency turning numbers into a decision
AI Governance Fluency using AI responsibly
Sustainability Fluency building care for people and planet into the work
Systems Fluency seeing the whole picture
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Your Plan Illustration

Built for Senior Medical Device Legal Specialist

5 units that map to this job, from the qualifications that cover it.

  1. Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety GQA Qualifications Limited · covers 3 of 9 standards Level 5
  2. Manage compliance to support achieving excellence in food operations FDQ Limited · covers 3 of 9 standards Level 3
  3. Principles of Safe Manufacture of Quality Medicines in the Pharmaceutical Environment Open Awards · covers 3 of 9 standards Level 3
  4. Providing initial health and community care legal information and advice ProQual Awarding Body · covers 1 of 9 standards Level 3
  5. Comply with External and Internal Obligations within a Bulk Storage Operations Environment GQA Qualifications Limited · covers 1 of 9 standards Level 3
These are the real units behind this job, in the order they rank for it. Nothing here is marked done, because this plan has not been started by anyone yet. Yours would fill in as you go.

2AI and this work

Will AI change your work as a Senior Medical Device Legal Specialist?

Nobody can say exactly how. Here is what this job is being asked for next, and where to start.

The new skills this role is being asked for

  • AI & Digital Health Legal Frameworks
  • Global Supply Chain & ESG Legal Risks
Why each one is rising

The future skills this job leans on

We'll only ever tell you what we can actually back up. No hype, no scare tactics.

What happens when you start

Next, a free account. We build your Senior Medical Device Legal Specialist plan as you set up, starting with a Future Fluency module on using AI in your job. No card.

Your first Future Fluency module is free. After that, your AI tutor is £70 a month.

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3What this role really is

This job involves making sure medical devices meet legal and regulatory requirements before they reach the market. It means working through regulations in detail, supporting new product launches, and identifying legal risks before they become problems.

4What you'd actually use

The tools this job runs on, and how well you'd need to know each one.

Westlaw Edge / Lexis Advance Advanced

Constructing complex Boolean searches for case law and statutes, leveraging specialised databases (e.g., FDA warning letters), and training junior colleagues on efficient research techniques.

iManage Work / NetDocuments Expert

Designing workspace templates for new matters, managing user permissions, and leading data migration efforts for significant legal projects. You'll be the go-to for document management best practices.

Veeva Vault (QualityDocs, RIM) / MasterControl Advanced

Auditing system data for compliance, collaborating with Quality on CAPA resolution, and drafting legal assessments within the Quality Management System (QMS) to ensure regulatory adherence.

RelativityOne / Logikcull Advanced

Building review workflows for eDiscovery, running search term reports (STRs), and managing document productions to outside counsel or regulators during litigation or investigations.

Icertis / Conga CLM / Ironclad Expert

Developing and customising contract templates, building complex approval workflows for various agreement types, and using platform analytics to identify negotiation bottlenecks and improve efficiency.

5What you get to decide, and how that grows

Power in a job isn't your title. It's what you're allowed to decide. Here's how it grows as you move up.

The choiceComing in Where you are nowThe step above
Contract Clause Approval Drafts standard clauses; all deviations require supervisor approval. Approves routine clauses within established playbooks; escalates non-standard terms. Approves complex clauses and minor deviations from playbooks; consults Lead Counsel on high-risk, novel terms.
Regulatory Interpretation Researches specific regulations; supervisor interprets and advises. Independently interprets routine regulations; proposes application to business. Provides definitive interpretations for non-routine regulations; advises on strategic implications and risk mitigation.
Ad/Promo Material Sign-off Reviews for basic compliance; supervisor provides final sign-off. Provides initial compliance review and flags issues; supervisor gives final approval. Provides final legal sign-off for most ad/promo materials; escalates only highly ambiguous or high-risk claims.
Project Timeline Changes (Legal Impact) Informs supervisor of any potential delays. Proposes adjustments to legal review timelines for manager approval. Recommends and sometimes approves minor adjustments to legal workstream timelines, informing relevant project leads and Lead Counsel.

6How you'll be judged

The scoreboard, and what is not on it. The hard targets, how often each is actually looked at, and the quiet signals that never reach a dashboard.

Regulatory Review Turnaround Time
How quickly you complete legal reviews of regulatory submissions or key documents.
Target · 95% of critical reviews completed within agreed 5-day SLA

If the R&D team needs a legal sign-off on a 510(k) submission draft, you'll get it back to them, with clear feedback, within five working days, most of the time. This helps keep our launch timelines on track.

Ad/Promo Material Compliance Rate
The percentage of marketing and promotional materials you review that are approved without needing significant legal changes due to non-compliance.
Target · 90% of materials approved on first or second review cycle

You review a new ad campaign for our latest device. If only 1 in 10 campaigns needs a major overhaul because of off-label claims, you're doing well. It means you're catching issues early and guiding the team effectively.

Contract Negotiation Cycle Time (CTAs)
The average time it takes to negotiate and finalise Clinical Trial Agreements (CTAs) you're leading.
Target · Reduce average CTA negotiation time by 15% year-on-year

Last year, it took us 60 days on average to get a CTA signed. This year, you've streamlined the process, perhaps by improving templates, and now it's down to 51 days. That's a tangible win for our clinical programmes.

Mentee Progression
The measurable development and progression of junior legal specialists you mentor.
Target · At least one mentee promoted to the next level within 24 months

You've been working with a Junior Legal Specialist for 18 months. They're now independently handling routine contract reviews and contributing to regulatory filings. This means they're ready for that next step, and you've played a big part in it.

Proactive Risk Identification
How well you anticipate and flag potential legal or regulatory risks before they become problems.
  • You're regularly bringing up potential issues in project meetings, not just reacting to them. Teams come to you early for advice, even before they've finalised their plans. You're seen as someone who helps avoid pitfalls, not just fixes them.
Clarity of Legal Advice
Your ability to explain complex legal concepts in a way that non-legal teams (like engineers or marketers) can easily understand and act upon.
  • Internal clients consistently tell us your advice is clear and actionable, not just 'legalese'. They don't need to come back with follow-up questions because your initial guidance was comprehensive. You're known for making things simple, not complicated.
Cross-Functional Collaboration
Your effectiveness in working with other departments to achieve compliant outcomes.
  • You're regularly invited to early-stage project discussions, not just brought in at the last minute. Teams feel you're a partner, not a roadblock. You help bridge gaps between departments, getting everyone on the same page regarding legal requirements.
Judgment in Ambiguous Situations
Your ability to make sound legal recommendations when the regulatory guidance isn't perfectly clear.
  • When faced with a grey area, you present well-reasoned options, outlining the risks and benefits of each. You're comfortable making a call and defending it, even when there's no black-and-white answer. Your recommendations are trusted, especially when the stakes are high.

7Would you like it

Both sides. What people enjoy, and what grinds them down.

What people enjoy
Protecting the Company

You get a genuine sense of satisfaction from spotting a risk that others missed or successfully guiding a product through a complex regulatory hurdle. You see your work as a shield for the business.

Successfully advising on a product labelling change that prevents a potential 'failure to warn' lawsuit, knowing you've saved the company millions and protected patients.

Intellectual Challenge

You thrive on dissecting complex regulations, interpreting ambiguous guidance documents, and figuring out how they apply to our specific, innovative devices. It's like solving a really tricky puzzle every day.

Spending weeks poring over a new EU MDR guidance document to determine the precise risk classification for a novel device, then presenting a clear, defensible position to the business.

Making a Tangible Impact

You're driven by the knowledge that your work directly contributes to getting safe, effective medical devices into the hands of patients. You see the bigger picture beyond just legal documents.

Seeing a product you helped navigate through the regulatory approval process successfully launch and knowing it's improving people's lives.

What frustrates people
  • Being perceived as a roadblock by commercial and R&D teams who prioritise speed-to-market over meticulous compliance.
  • Spending weeks interpreting ambiguous regulatory guidance that's intentionally vague, leaving the company to make a multi-million pound bet in a grey area.
  • Receiving a 50-page slide deck for a major product launch presentation at 4 PM on a Friday, with a deadline of EOD.
  • Discovering that sales reps have created their own 'unapproved' marketing materials to close deals, creating massive off-label promotion risk.
  • The sheer, soul-crushing volume of documentation that must be reviewed with zero tolerance for error, from 1,000-page regulatory filings to mind-numbing Standard Operating Procedures (SOPs).
What this role does not give you
  • A 'move fast and break things' culture – we absolutely cannot break things here.
  • A role where you're always the hero getting cheers from the business; sometimes you're the one delivering tough news.
  • A predictable, routine workload; urgent regulatory changes and unexpected issues are just part of the job.
  • The chance to ignore the minutiae; details are everything in medical device law.

8Who you work with

This role directly protects the company's licence to operate and its reputation. Your advice prevents regulatory penalties, product liability claims, and ensures our devices meet the highest safety and efficacy standards. You're essentially safeguarding our revenue streams and market access.

Inside the business
  • R&D and Engineering teams (especially during product design and testing)
  • Product Management (for launch strategies and claims)
  • Quality Assurance & Regulatory Affairs (for QMS and submissions)
  • Marketing & Sales (for advertising and promotional materials)
  • Clinical Affairs (for trial agreements and data integrity)
Outside the business
  • External legal counsel (for specialist advice or litigation support)
  • Regulatory bodies (e.g., MHRA, EU Notified Bodies, FDA)
  • Industry associations (for best practices and policy monitoring)
  • Contract Research Organisations (CROs) and clinical sites

9What you need before you start

Not a wish list. The things you would be expected to already have.

  • You'll need at least 5 years of dedicated legal experience, specifically within the medical device or a closely related highly regulated industry (e.g., pharmaceuticals, biotech).
  • A proven track record of successfully managing legal workstreams for product launches or significant regulatory submissions.
  • Demonstrable experience in drafting and negotiating complex commercial or clinical agreements.
  • A strong understanding of the interplay between legal, regulatory, and quality functions in a medical device company. You've seen how these teams work together, or sometimes, don't.
  • The ability to work independently, manage multiple priorities, and deliver high-quality legal work under pressure. Nobody's holding your hand here, but support is always available.

10What to practise next

Where the job is going, and what to do about it starting this week.

Advanced Legal Tech & Automation

Legal departments are finally catching up with technology. You'll need to move beyond basic document management to actively identify and implement legal tech solutions that automate routine tasks, improve efficiency, and enhance compliance monitoring. If you're not using these tools, you'll be left behind.

No-Code/Low-Code Legal Automation · Legal Data Analytics · Blockchain for IP & Supply Chain · Virtual Data Rooms (VDRs) for Due Diligence

  • This month: Explore the automation features within our existing CLM or DMS. What can it already do that we're not using?
  • Next quarter: Identify one repetitive legal task (e.g., drafting NDAs) and research a low-code automation tool that could help. Maybe it's a simple template generator.
  • Next 6 months: Pilot a small automation project within the legal team. Show us what you can do.
  • Next year: Present a business case for investing in a new legal tech solution that could save us significant time or reduce risk.

Quick win: Start using advanced search functions and custom reporting in your existing legal software. You'd be surprised what's already there.

11Staying current once you are in

What people here do to keep up
  • Regularly attend industry conferences and workshops focused on medical device law and regulation (e.g., RAPS Regulatory Convergence, MedTech Europe events).
  • Participate in legal professional networks or special interest groups dedicated to healthcare or life sciences law.
  • Stay current with legal publications and journals, subscribing to alerts for key regulatory bodies like the MHRA, FDA, and European Commission.
  • Seek out opportunities to mentor junior colleagues or deliver internal training sessions on specific legal topics. Teaching is a great way to deepen your own understanding.
  • Engage in pro bono legal work, if time permits, to keep your general legal skills sharp and contribute to the community.

12The rising capability

The rising capability

Zavmo analysis

What's rising in its place

This is where the work is heading, and the higher pay with it. Get fluent here and the shift stops being a threat and starts being your edge.

AI & Digital Health Legal Frameworks

The rapid development of AI/ML-powered medical devices and digital health solutions (apps, wearables) means new legal and ethical questions are popping up daily. Regulators are scrambling to catch up, and we need someone who can interpret the emerging guidance and advise us proactively.

  • AI as a Medical Device (AI/ML SaMD)
  • Data Governance & Ethics for AI
  • Cybersecurity for Digital Health
  • Interoperability & Data Sharing

Global Supply Chain & ESG Legal Risks

Increasing scrutiny on environmental, social, and governance (ESG) factors, coupled with complex global supply chains, means legal risks aren't just about the product anymore. They're about where components come from, labour practices, and environmental impact. Regulators and investors care, so we have to care.

  • Modern Slavery Act Compliance
  • Conflict Minerals Regulations
  • Environmental Regulations (e.g., WEEE, RoHS)
  • ESG Due Diligence

13What you’ll use

What you’ll use

Skills this role draws on

Technical

  • Regulatory Pathway Analysis
  • Product Liability & Risk Mitigation
  • FDA & Global Regulatory Compliance
  • Clinical Trial & Research Agreement Negotiation
  • Advertising & Promotion (Ad/Promo) Review
  • Government Investigations & Defence

14The pathway

The pathway

How you actually get there, here

How you become one varies far more by country than what one does. This is the UK route. Most people take one of these ways in; the right one depends on where you're starting from.

  1. 1

    In-house Legal Counsel (Medical Devices)

    5-7 years

    Skills to master

    • Deep specialisation in medical device regulatory frameworks, commercial contract negotiation, and product liability risk management. You'll have seen a few product launches and dealt with some tricky situations.

    You're ready to move on when

    • Successfully led legal workstreams for at least two major product launches.
    • Consistently provided clear, actionable legal advice to cross-functional business units.
    • Demonstrated ability to independently negotiate and finalise complex agreements.
    • Mentored junior team members or acted as a go-to person for specific legal areas.
  2. 2

    Private Practice (Life Sciences/Healthcare Law)

    6-8 years

    Skills to master

    • Extensive experience advising multiple medical device clients on regulatory compliance, M&A due diligence, and litigation support. You'll have a broad view of industry challenges and best practices.

    You're ready to move on when

    • Managed client relationships and delivered high-quality legal advice across various medical device sub-sectors.
    • Contributed to significant regulatory submissions or defended clients in enforcement actions.
    • Developed a reputation for expertise in a niche area of medical device law.
    • Proven ability to manage a demanding workload and client expectations.
  3. 3

    Regulatory Affairs Specialist (with Legal Focus)

    7-10 years

    Skills to master

    • A strong background in regulatory submissions, quality systems (e.g., ISO 13485), and post-market surveillance, combined with a legal qualification. This path means you've been on the 'other side' of the regulatory fence.

    You're ready to move on when

    • Successfully managed multiple medical device regulatory submissions (e.g., 510(k), CE Mark).
    • Demonstrated a deep understanding of Quality Management Systems and their legal implications.
    • Proven ability to interpret and apply complex regulatory guidance in a practical business context.
    • Actively collaborated with legal teams on compliance matters.

15Where this role leads

The long view: This work can lead to roles such as Associate General Counsel, Medical Device, or VP, Legal & Regulatory Affairs, Medical Device BU, with broader responsibility for legal and regulatory strategy.

The ten Future Fluencies

Zavmo analysis

The credential is what you can do today. These are what keep you valuable.

A qualification proves you can do the job as it's defined today. These ten are what decide whether you're still the obvious person for it in five years. They're the capabilities employers are now writing into senior roles faster than people are learning them. Zavmo weaves them through whatever you study, so you come out with both: the credential and the fluency.

The highlighted ones are the Fluencies your role leans on hardest, from how Senior Medical Device Legal Specialist is actually changing.

Where it leads

Roles this leads to

The record names a next step, but the catalogue has no page for it yet:

  • Lead Counsel, Medical Device Regulatory
  • Senior Legal Counsel (Generalist, Broader Scope)

How you would learn this

One to one, on the work you already do

A tutor sets the task against your own job and marks the reasoning, at your pace. There is no cohort to fall behind.

A lesson from Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety, worked against Senior Medical Device Legal Specialist.

Understand how to comply with the relevant Regulations, Industry Standards and Management Requirements for Process Safety Level 5

Applied to your work in Senior Medical Device Legal Specialist

The objective of this unit is to provide learners with a comprehensive understanding of the regulations, industry standards, and management requirements for process safety. Learners will understand the role of the Process Safety Leadership Group, relevant frameworks, legal duties, and the role of the Competent Authority.

How the thinking builds
  1. 1 Remember
  2. 2 Understand
  3. 3 Apply
  4. 4 Analyse
  5. 5 Evaluate
  6. 6 Create
An illustration of a Zavmo lesson, built from this role’s own route. The unit, its objective and every criterion above are the awarding body’s own words, not an example.

It is £70 a month, billed monthly. Your free first module is Future Fluency, and you can cancel any time.

Start my Senior Medical Device Legal Specialist plan, free
See Your Progress Grow Illustration
Senior Medical Device Legal Specialist
  • Regulatory Pathway Analysis
  • Product Liability & Risk Mitigation
  • FDA & Global Regulatory Compliance
  • Clinical Trial & Research Agreement Negotiation
  • Advertising & Promotion (Ad/Promo) Review
  • Government Investigations & Defence
This is your Mind Palace on learn.zavmo.ai. Every skill above comes from this role's own record, not an example borrowed from another job. A node lights up when you evidence it, and what you build stays yours between jobs. That is the part a course cannot do.

16The detail, folded away

Everything else the record holds

The career branches in full, how AI is already showing up in the day-to-day, and the questions people ask about this job. Here when you want them, out of the way while you decide.

Where it leads next, rung by rung

Where it leads

The career path, and where it branches

Senior Medical Device Legal Specialist is a start, not a ceiling. Each step below asks for new skills and hands back more autonomy.

  1. Lead Counsel, Medical Device Regulatory

    3-5 years

    L4

    • Regulatory Strategy Development Architecting long-term regulatory strategies for new markets or complex product portfolios.
    • Crisis Management Leading the legal response to major regulatory enforcement actions or product recalls.
    • M&A Legal Due Diligence Leading the legal review for potential acquisitions of medical device companies.
    • Outside Counsel Management Selecting, managing, and evaluating external law firms for specialist advice or litigation.

  2. Senior Legal Counsel (Generalist, Broader Scope)

    3-5 years

    L4

    • General Commercial Law Drafting and negotiating a wider range of commercial agreements (e.g., IT contracts, supplier agreements).
    • Employment Law Providing advice on HR-related legal issues, employee relations, and compliance.
    • Intellectual Property Portfolio Management Overseeing the company's broader IP strategy and enforcement.
    • Data Privacy & Cybersecurity (Enterprise-wide) Leading data privacy compliance across the entire organisation, not just product-specific.
Working with AI on the job

Working with AI

Where AI is starting to help

Let's be real, a lot of legal work is about wading through documents, spotting patterns, and drafting responses. AI isn't here to replace you, but it's brilliant at taking the grunt work off your plate. Imagine what you could do with an extra day or two each week.

For a Senior Medical Device Legal Specialist, AI can genuinely transform how you approach everything from contract review to regulatory intelligence. It means less time on the tedious stuff and more time on the truly strategic, high-value legal advice that only a human can provide.

Automated Clause Analysis

Use an AI-powered Contract Lifecycle Management (CLM) tool, like Icertis AI, to automatically scan new third-party contracts. It'll flag any non-standard clauses, highlight missing fallback positions, and give you a quick risk assessment against our pre-approved legal playbooks. This cuts down on your first-pass review time significantly.

Global Regulatory Intelligence

Leverage AI monitoring tools to constantly scan global regulatory body websites, news feeds, and government publications. You'll get daily summarised briefings on any proposed or enacted changes that could impact our product portfolio. No more sifting through endless government gazettes yourself; the AI does the heavy lifting.

eDiscovery Document Prioritisation

When you're faced with a mountain of documents for eDiscovery, use AI tools within platforms like Relativity (think Active Learning). It'll analyse an initial document set and then predictively code the rest, prioritising the most relevant documents for your human review. This can drastically reduce the time spent on initial document review during litigation.

First-Draft Generation

Employ a secure, internal generative AI model to create initial drafts of common legal documents. This could be anything from responses to routine physician inquiries, to summaries of new regulations for our business teams, or even updates to Standard Operating Procedures (SOPs). You'll shift your focus from staring at a blank page to strategically editing and refining.

Common questions

Common questions

How do you become a Senior Medical Device Legal Specialist?

Common routes in include In-house Legal Counsel (Medical Devices) (5-7 years), Private Practice (Life Sciences/Healthcare Law) (6-8 years) and Regulatory Affairs Specialist (with Legal Focus) (7-10 years). Times vary with prior experience.

Where can a Senior Medical Device Legal Specialist progress to?

This role can lead on to Lead Counsel, Medical Device Regulatory (3-5 years) and Senior Legal Counsel (Generalist, Broader Scope) (3-5 years), depending on the skills you build.

What new skills matter most for a Senior Medical Device Legal Specialist?

Increasingly, AI & Digital Health Legal Frameworks and Global Supply Chain & ESG Legal Risks. These are the skills our record of this role lists as growing.

Free tools

Want a read on where you stand?

Three free tools, no account needed. Each one ends with a role, a level and a way in.

Read the Zavmo manifesto to understand how you will be taught Meet your tutors

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17Where to go from here

Other roles at Level 5

Same depth of qualification, different job. Useful if the work appeals but this particular role does not.

 More jobs in legal

Stay in the field you know and move sideways rather than up.
If you leave this industry

Expertise in medical device regulation carries across other regulated sectors, including pharmaceuticals, biotechnology and digital health. The skills involved, working through complex legal frameworks and managing risk, apply widely.

This role profile is © 2026 Growth Engineering Technologies Ltd. Built from UK occupational standards and regulated qualification data, and written for Zavmo.

You're not behind. You're right on time. The shift is only just beginning. Your role won't look the same in two years. Be the one who leads the change, not the one it happens to. Start my Senior Medical Device Legal Specialist plan, free What happens next: a free account, then we build your plan as you set up. No card. Build your plan, see your roadmap and meet the twelve tutors matched to you. All free. When you're ready to start learning, it's £70 a month, billed monthly. Cancel any time and billing stops.